Training Program for Regulatory Project Managers; Information Available to Industry, 10538 [2012-4034]
Download as PDF
<![CDATA[
10538
Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Notices
• Recalls—Globally;
• GHTF Document on CAPA—
Workshop;
• 510(k)—An Industry Perspective;
• Interdependency of Postmarket
Surveillance, Risk, and CAPA;
• Promotional Practices—Global;
• Office of Compliance Initiatives;
• U.S. Senate HELP Committee
Keynote Dinner;
• Risk Management Across the
Quality Systems—FDA Expectations
and Implementation;
• Global Regulatory Strategy; and
• FDA Inspectional Approach—Panel
With Current FDA Investigators.
FDA has made education of the drug
and device manufacturing community a
high priority to help ensure the quality
of FDA-regulated drugs and devices.
The conference helps to achieve
objectives set forth in section 406 of the
Food and Drug Administration
Modernization Act of 1997 (Pub. L. 105–
115) (21 U.S.C. 393), which includes
working closely with stakeholders and
maximizing the availability and clarity
of information to stakeholders and the
public. The conference also is consistent
with the Small Business Regulatory
Enforcement Fairness Act of 1996 (Pub.
L. 104–121) by providing outreach
activities by Government Agencies to
small businesses.
Dated: February 15, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–4036 Filed 2–21–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0093]
Training Program for Regulatory
Project Managers; Information
Available to Industry
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration’s (FDA) Center for Drug
Evaluation and Research (CDER) is
announcing the continuation of the
Regulatory Project Management Site
Tours and Regulatory Interaction
Program (the Site Tours Program). The
purpose of this document is to invite
pharmaceutical companies interested in
participating in this program to contact
CDER.
DATES: Pharmaceutical companies may
submit proposed agendas to the Agency
by April 23, 2012.
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
16:37 Feb 21, 2012
Jkt 226001
Dan
Brum, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, rm. 4160, Silver Spring,
MD 20993–0002, 301–796–0578, email:
dan.brum@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
FOR FURTHER INFORMATION CONTACT:
I. Background
An important part of CDER’s
commitment to make safe and effective
drugs available to all Americans is
optimizing the efficiency and quality of
the drug review process. To support this
primary goal, CDER has initiated
various training and development
programs to promote high performance
in its regulatory project management
staff. CDER seeks to significantly
enhance review efficiency and review
quality by providing the staff with a
better understanding of the
pharmaceutical industry and its
operations. To this end, CDER is
continuing its training program to give
regulatory project managers the
opportunity to tour pharmaceutical
facilities. The goals are to provide the
following: (1) Firsthand exposure to
industry’s drug development processes
and (2) a venue for sharing information
about project management procedures
(but not drug-specific information) with
industry representatives.
II. The Site Tours Program
In this program, over a 2- to 3-day
period, small groups (five or less) of
regulatory project managers, including a
senior level regulatory project manager,
can observe operations of
pharmaceutical manufacturing and/or
packaging facilities, pathology/
toxicology laboratories, and regulatory
affairs operations. Neither this tour nor
any part of the program is intended as
a mechanism to inspect, assess, judge,
or perform a regulatory function, but is
meant rather to improve mutual
understanding and to provide an avenue
for open dialogue. During the Site Tours
Program, regulatory project managers
will also participate in daily workshops
with their industry counterparts,
focusing on selective regulatory issues
important to both CDER staff and
industry. The primary objective of the
daily workshops is to learn about the
team approach to drug development,
including drug discovery, preclinical
evaluation, tracking mechanisms, and
regulatory submission operations. The
overall benefit to regulatory project
managers will be exposure to project
management, team techniques, and
processes employed by the
pharmaceutical industry. By
participating in this program, the
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
regulatory project manager will grow
professionally by gaining a better
understanding of industry processes and
procedures.
III. Site Selection
All travel expenses associated with
the site tours will be the responsibility
of CDER; therefore, selection will be
based on the availability of funds and
resources for each fiscal year. Selection
will also be based on firms having a
favorable facility status as determined
by FDA’s Office of Regulatory Affairs
District Offices in the firms’ respective
regions. Firms interested in offering a
site tour or learning more about this
training opportunity should respond by
submitting a proposed agenda to Dan
Brum (see DATES and FOR FURTHER
INFORMATION CONTACT).
Dated: February 14, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–4034 Filed 2–21–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Heart, Lung,
and Blood Institute Special Emphasis Panel;
Cardiothoracic Surgery Program.
Date: March 12, 2012.
Time: 11 a.m. to 1 p.m.
Agenda: To review and evaluate contract
proposals.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Chang Sook Kim, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6701 Rockledge Drive, Room
7179, Bethesda, MD 20892–7924, 301–435–
0287, carolko@mail.nih.gov.
E:\FR\FM\22FEN1.SGM
22FEN1
]]>Agencies
[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Notices]
[Page 10538]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4034]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0093]
Training Program for Regulatory Project Managers; Information
Available to Industry
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration's (FDA) Center for Drug
Evaluation and Research (CDER) is announcing the continuation of the
Regulatory Project Management Site Tours and Regulatory Interaction
Program (the Site Tours Program). The purpose of this document is to
invite pharmaceutical companies interested in participating in this
program to contact CDER.
DATES: Pharmaceutical companies may submit proposed agendas to the
Agency by April 23, 2012.
FOR FURTHER INFORMATION CONTACT: Dan Brum, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, rm. 4160, Silver Spring, MD 20993-0002, 301-796-0578, email:
dan.brum@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
An important part of CDER's commitment to make safe and effective
drugs available to all Americans is optimizing the efficiency and
quality of the drug review process. To support this primary goal, CDER
has initiated various training and development programs to promote high
performance in its regulatory project management staff. CDER seeks to
significantly enhance review efficiency and review quality by providing
the staff with a better understanding of the pharmaceutical industry
and its operations. To this end, CDER is continuing its training
program to give regulatory project managers the opportunity to tour
pharmaceutical facilities. The goals are to provide the following: (1)
Firsthand exposure to industry's drug development processes and (2) a
venue for sharing information about project management procedures (but
not drug-specific information) with industry representatives.
II. The Site Tours Program
In this program, over a 2- to 3-day period, small groups (five or
less) of regulatory project managers, including a senior level
regulatory project manager, can observe operations of pharmaceutical
manufacturing and/or packaging facilities, pathology/toxicology
laboratories, and regulatory affairs operations. Neither this tour nor
any part of the program is intended as a mechanism to inspect, assess,
judge, or perform a regulatory function, but is meant rather to improve
mutual understanding and to provide an avenue for open dialogue. During
the Site Tours Program, regulatory project managers will also
participate in daily workshops with their industry counterparts,
focusing on selective regulatory issues important to both CDER staff
and industry. The primary objective of the daily workshops is to learn
about the team approach to drug development, including drug discovery,
preclinical evaluation, tracking mechanisms, and regulatory submission
operations. The overall benefit to regulatory project managers will be
exposure to project management, team techniques, and processes employed
by the pharmaceutical industry. By participating in this program, the
regulatory project manager will grow professionally by gaining a better
understanding of industry processes and procedures.
III. Site Selection
All travel expenses associated with the site tours will be the
responsibility of CDER; therefore, selection will be based on the
availability of funds and resources for each fiscal year. Selection
will also be based on firms having a favorable facility status as
determined by FDA's Office of Regulatory Affairs District Offices in
the firms' respective regions. Firms interested in offering a site tour
or learning more about this training opportunity should respond by
submitting a proposed agenda to Dan Brum (see DATES and FOR FURTHER
INFORMATION CONTACT).
Dated: February 14, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4034 Filed 2-21-12; 8:45 am]
BILLING CODE 4160-01-P
